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GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601402
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Merck KGaA, Darmstadt, Germany
Pfizer
Information provided by (Responsible Party):
Genome & Company

Brief Summary:
This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

Condition or disease Intervention/treatment Phase
Solid Tumor Non Small Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Urothelial Carcinoma Drug: GEN-001 Drug: Avelumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Dose Escalation: Seqeuntial Group Assignment, Dose Expansion: Parallel Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: GEN-001 with avelumab

Dose Escalation Cohort includes patients with advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels.

Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)will be enrolled.

Drug: GEN-001
The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10^11 colony-forming units (CFU)

Drug: Avelumab
800 mg given by intravenous (IV) infusion once every 2 weeks
Other Name: Bavencio




Primary Outcome Measures :
  1. Dose Escalation: Incidence of Adverse Events [ Time Frame: 1 years ]
    Assessed as per CTCAE v5.0

  2. Dose Escalation: Incidence of Laboratory abnormalities [ Time Frame: 1 years ]
    Assessed as per CTCAE v5.0

  3. Dose Escalation: Incidence of dose-limiting toxicity (DLT) [ Time Frame: 1 Cycle (one cycle = 28 days) ]
    To evaluate the safety and tolerability of GEN-001 in combination with avelumab

  4. Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab. [ Time Frame: 2 years ]
    Confirmed OR per RECIST v1.1 by the Investigator


Secondary Outcome Measures :
  1. Objective Response (OR) [ Time Frame: 1 years ]
    Assessed according to RECIST v1.1

  2. Duration of response (DoR) [ Time Frame: up to 2 years ]
    Assessed according to RECIST v1.1

  3. Progression-free survival (PFS) [ Time Frame: up to 2 years ]
    Assessed according to RECIST v1.1

  4. Overall Survival (OS) [ Time Frame: up to 2 years ]
  5. Incidence of Adverse Events [ Time Frame: up to 2 years ]
    Assessed as per CTCAE v5.0

  6. Incidence of Laboratory Abnormalities [ Time Frame: up to 2 years ]
    Assessed as per CTCAE v5.0

  7. irOR (Immune-related Objective Response) [ Time Frame: up to 2 years ]
    Assessed according to irRECIST


Other Outcome Measures:
  1. Ctrough [ Time Frame: up to 2 years ]
    Ctrough for PK parameter

  2. ADA [ Time Frame: up to 2 years ]
    Anti-Drug Antibodies(ADA) for Immunogenicity

  3. Microbiota [ Time Frame: up to 2 years ]
    fecal samples will be collected for analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ functions as defined in the protocol
  • Negative childbearing potential
  • Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities
  • Patients with diseases for which no curative therapies are available, and who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)
  • Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
  • Patients who have completely recovered from any clinically significant AEs that occurred during prior immunotherapy
  • Estimated life expectancy of at least 3 months
  • Objective evidence of disease progression at baseline (Dose Escalation)
  • Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic NSCLC, SCCHN, and UC (Dose Expansion)
  • Measurable disease as per RECIST v1.1 defined as at least 1 lesion (Dose Expansion)

Exclusion Criteria:

  • Have experienced primary resistance to anti-PD-(L)1 based therapy
  • Has experienced a toxicity that led to permanent discontinuation of prior anti-PD-(L)1 based therapy or other immunotherapies
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Current use of immunosuppressive medication at time of study entry
  • Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within the previous 4 weeks of starting study treatment
  • Has received a live vaccine within 4 weeks of starting of study treatment
  • Known history of, or any evidence of active, non-infectious pneumonitis
  • Prior solid organ or allogeneic stem cell transplantation
  • Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks of starting study treatment
  • Has received proton pump inhibitors (PPIs) within 2 weeks prior to dosing study treatments
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has clinically significant (i.e., active) cardiovascular disease
  • Has known history of uncontrolled intercurrent illness
  • Has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601402


Contacts
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Contact: Clinical Development +82316280150 GNC_Clinical@genomecom.co.kr

Locations
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United States, Connecticut
Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory University Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Genome & Company
Merck KGaA, Darmstadt, Germany
Pfizer
Investigators
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Principal Investigator: Shivaani Kummar, MD Oregon Health and Science University
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Responsible Party: Genome & Company
ClinicalTrials.gov Identifier: NCT04601402    
Other Study ID Numbers: [GNC] GEN001-101
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Head and Neck Neoplasms